ISO 7101:2023
Quality Management for Healthcare Organisations
ISO 7101 (2023) is a management system standard: Quality Management for Healthcare Organisations. Specifies management system requirements for quality in healthcare organisations, covering healthcare service management. It applies to hospitals, clinics and healthcare service providers.
- Class
- Management system standard
- Edition
- 2023
- Related sectors
- 1
- Last verified
What is this standard?
Specifies management system requirements for quality in healthcare organisations, covering healthcare service management.
What ISO 7101 does not replace
- Medical device manufacturers, medical laboratories and clinical services are not the same record; ISO 15189 is an accreditation for laboratories.
- It does not substitute for a healthcare facility licence.
Who is it for?
Hospitals, clinics and healthcare service providers.
What triggers an assessment?
- A corporate quality framework is wanted for healthcare service management.
- Patient safety and service quality need to be measured.
- A corporate customer or insurer wants quality assurance.
Official source
Last verified:
This page is for information only; it is not legal advice. A record appearing here does not mean it is required for your business. This library does not issue certificates.